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Non-Invasive Spinal Cord Stimulation for Respiratory Distress Syndrome

N/A

Recruiting

Led By Daniel Lu, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to induce evoked response of diaphragm muscle by spinal cord TES

Enrollment of subject within 48 hours of intubation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-48 months

Awards & highlights

Study Summary

This trial will test if non-invasive spinal cord stimulation can help prevent respiratory muscle atrophy in ARDS patients on mechanical ventilation. 10 elective surgery & 10 ARDS patients will be tested with a Restore Technology stimulator.

Who is the study for?

This trial is for ICU patients aged 18-85 who've had non-cardiac surgery or have ARDS, can consent (or their kin can), and were intubated within the last 48 hours. They must be able to respond to spinal cord stimulation with intact anatomy and connections between the spinal cord and respiratory muscles. Excluded are those with seizure histories, skin issues on the back, certain implants, a BMI of 35 or higher, or pregnancy.Check my eligibility

What is being tested?

The study tests a non-invasive electrical stimulator on two groups: post-surgery patients and ARDS sufferers. It aims to prevent muscle weakening from long ventilator use by stimulating the spinal cord at specific points using surface electrodes.See study design

What are the potential side effects?

Potential side effects may include discomfort at the electrode site, unintended muscle contractions during stimulation, skin irritation from hydrogel electrodes, and in rare cases could potentially trigger seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diaphragm muscle responds to spinal cord stimulation.

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I was put on a breathing machine within the last 2 days.

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I was admitted to the ICU following a non-heart related surgery.

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My chest, arms, and legs are structurally normal.

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My nerves connecting my spinal cord to my breathing muscles are working.

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I am on a ventilator due to severe lung injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recording of significant stimulation-induced adverse events (AE)

Secondary outcome measures

Assessment of diaphragm and respiratory muscle EMG amplitudes

Assessment of respiratory tidal volume

Measurement of diaphragm thickness

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Surgery Cohort (Active)Experimental Treatment1 Intervention

Patient undergoing inpatient non-cardiac surgery admitted to the intensive care unit (ICU) after surgery. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

Group II: ARDS cohortExperimental Treatment1 Intervention

Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,248 Total Patients Enrolled

3 Trials studying Respiratory Distress Syndrome

3,060 Patients Enrolled for Respiratory Distress Syndrome

Daniel Lu, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

ARDS cohort Clinical Trial Eligibility Overview. Trial Name: NCT05928052 — N/A

Respiratory Distress Syndrome Research Study Groups: ARDS cohort, Surgery Cohort (Active)

Respiratory Distress Syndrome Clinical Trial 2023: ARDS cohort Highlights & Side Effects. Trial Name: NCT05928052 — N/A

ARDS cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT05928052 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room to enroll participants in this research project?

"Yes, current information on clinicaltrials.gov indicates that this investigation is presently enrolling volunteers. It was initially published on July 1st 2022 and has recently been updated June 22nd 2023 with the aim of enlisting 20 individuals at a single facility."

Answered by AI

How numerous are the participants in this clinical trial?

"Correct. Data hosted on clinicaltrials.gov verifies that this medical trial is actively recruiting participants, with the first advertisement published on July 1st 2022 and updated as recently as June 22nd 2023. The researchers are currently searching for a total of 20 patients to enrol at one specific site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

Daniel Lu, MD, PhD 2022. "Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05928052.

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